Reported Feb 14, 2018 · Terminated
ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811,…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc · 333 Coney St · East Walpole, MA · 02032-1516
Is this the product you have?
ADVIA Centaur Calibrator 302 pack6 packand Ref 2 pack
- Siemens Material Number (SMN)
103798101037981110697756
- Lot codes and dates
- Lot Numbers
00387A2116673A2136243A2100388A2115448A2151211A2120640A2151024A21
- Expiration Date2018-03-08
- Lot Numbers
- Amount recalled
- 5992 units (US and OUS)
Why it was recalled
Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur Enhanced Estradiol (eE2) on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems when calibrating with Calibrator 30 kit lots ending in 21 (C3021) as compared to Calibrator 30 kit lots ending in 20 (C3020).
This product could cause temporary or reversible health problems — stop using it.
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